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When patients want 'alternative' care

Ethics case study: how to respond to requests for these therapies

From the July/August 1998 ACP-ASIM Observer, copyright 1998 by the American College of Physicians-American Society of Internal Medicine.

This is the 20th in a series of case studies with commentaries developed by the ACP-ASIM Ethics and Human Rights Committee. The series uses hypothetical cases to elaborate on controversial or subtle aspects of issues not addressed in detail in the "ACP Ethics Manual" or in other position statements.

Case history

A 47-year-old man comes to your office with classic angina pectoris. While you don't have information on his cholesterol levels, you know that he is nondiabetic, normotensive and a former smoker with a positive family history of coronary disease. The patient eventually undergoes angiography. Coronary artery disease is found with a 90% lesion in the left anterior descending artery and nonobstructive plaque in his remaining coronary arteries. A coronary stent is successfully placed, and the patient sees you in follow-up.

After successfully completing cardiac rehabilitation, his total cholesterol is greater than 300mg/dl with an LDL cholesterol of 230mg/dl, well above the 100mg/dl suggested by guidelines from the National Cholesterol Education Project. Even after appropriate dietary changes and weight loss, the patient's cholesterol remains elevated, so you suggest cholesterol-lowering therapy, specifically an HMG Co-A reductase inhibitor.

"You know, doc, I'm not much for medicines," the patient states. "Isn't there another way?" You discuss the sequential steps of diet and weight loss you've already initiated. You also explain the scientific data available for this class of medicine, including improved survival when used for the secondary prevention of coronary disease. "That's fine, doc," the patient replies, "but I've read quite a bit about chelation therapy and would prefer to try that first." While there are "alternative treatments" that have value, you do some research and find that chelation therapy can be harmful and that there is no evidence of its effectiveness.

When the patient returns after four months of undergoing chelation therapy three times a week, his LDL cholesterol remains elevated at 227. Despite your recommendations against chelation therapy and the patient's own experience with its ineffectiveness, he agrees to take the reductase inhibitor—but only if he can continue with chelation therapy.

Commentary

Chiropractic, chelation, high-dose vitamins and herbal therapies such as St. John's Wort and Ginkgo biloba are among the myriad of "alternative treatments" currently enticing and perplexing patients and physicians alike. With approximately $13 billion a year being spent in the United States on these therapies, there must be reasons why patients seek out and use these remedies in addition to—or instead of—conventional medicines. (1)

Dealing with the issue has certainly become a challenge for physicians. What constitutes an alternative therapy, and why are such therapies so popular? From a practical and ethical perspective, how should practitioners advise patients who use these methods or preparations? What are our responsibilities as far as knowing about these therapies?

Alternative therapies, as they have become known, can range from innocuous family remedies to unproven but potentially promising remedies to harmful and ineffective treatments. Many physicians take issue with the term "alternative," feeling it gives a degree of legitimacy to therapies that may or may not be effective. For example, in conventional medicine, alternative usually refers to options within generally accepted medical practices, such as medical vs. surgical therapy for coronary artery disease. One common definition of alternative medicine refers to therapies not widely taught in medical schools, not generally used in hospitals and not typically reimbursed by medical insurance companies. (1) More than 50 medical schools in the United States now offer courses in alternative medicine.

At its methodology conference in 1995, the recently established National Institutes of Health Office of Alternative Medicine adopted the definition of complementary and alternative medicine (CAM) as "a broad domain of healing resources that encompasses all health systems, modalities and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and the domain of the dominant system are not always sharp or fixed." (2)

We certainly don't want to alienate or antagonize our patients when they ask for this information. Also, since data suggest that a large number of patients already use these therapies, it is physicians' responsibility to inquire about their use in a neutral, nonthreatening manner and to elicit this information in the context of the doctor-patient relationship. We need to know what else our patients are taking or doing in order to prescribe conventional treatments safely and effectively. Just as we ask about nonprescribed medicines, such as over-the-counter medicines, we should ask about other modalities patients may be using in addition to—or instead of—conventional methods. Obtaining this information in a respectful manner recognizes patients' roles as partners in their medical care. The key is asking questions in a nonjudgmental way to obtain information necessary to treatment. How physicians respond to the answers can also determine how honest the patient will be with future inquiries.

Once the discussion has been initiated, the physician should find out why patients may be seeking or using alternative therapies and what benefits they hope to obtain. David M. Eisenberg, ACP-ASIM Member, summarized the diverse reasons patients explore alternative therapies:

"1. They seek health promotion and disease prevention; 2. Conventional therapies have been exhausted; 3. Conventional therapies are of indeterminate effectiveness or commonly associated with side effects or significant risk; 4. No conventional therapy is known to relieve the patient's condition; and 5. The conventional approach is perceived to be emotionally or spiritually without benefit." (3)

Understanding these reasons should help physicians structure discussions regarding alternative therapies in a manner that addresses patients' specific needs.

Physicians should also ask patients about their understanding of and experiences with alternative and conventional therapies. This line of questioning can lead to a discussion about why we base our recommendations on available scientific evidence. We should be able to share with patients the data that exist for the therapies we recommend. In addition, physicians should also be willing to help research, within reason, alternative therapies about which patients may have questions. (See "On the Web").

Helping research such therapies shows patients that we are willing to work with them to achieve their best possible health status. It also shows that we are open-minded and willing to learn (since one of our roles as physicians is as educator), and it demonstrates to patients the systematic approach we use to evaluate both conventional and alternative therapies, which is the foundation of medical treatment and advances. By understanding what data are available—within the limitations of our busy practices—we can act as educated patient advocates by pointing out shortcomings or misinformation to patients.

However, when discussing alternative medicine with patients, we must be careful not to overstep our level of expertise. If we don't know anything about an area or practice, we shouldn't provide an opinion or misinformation. For example, a patient might interpret a casual remark like "It probably can't hurt you" as a recommendation to try something.

We should also be careful to structure these discussions in scientific—not emotional—terms. We may emphasize that testimonials are not adequate evidence, but we should also be prepared to defend our own methods of practice when less than ideal data exist. We should be willing to admit that what we offer may not be perfect, and that alternative approaches may have benefits of which we may not be aware. By framing the discussion in an atmosphere of openness, honesty and intellectual curiosity, we convey to patients that their well-being is truly our primary concern.

In counseling the patient in the above case study, it may be helpful to use a classification system to frame the discussion. This system can be used for any therapeutic modality—alternative or conventional—since it is based upon the level of evidence available regarding its effectiveness and use. John Renner, MD, has proposed the following five-point classification scheme: (4)

  • Quackery. These therapies are marketed and claims are usually offered as testimonials that are not documented or based on a reasonable pathophysiologic rationale or valid evidence of efficacy. Quackery exploits patients' fears or desires, though well- informed patients sometimes desire this course, as in the present case.
  • Folklore. This refers to a class of preparations based on family tradition that is handed down through generations. These remedies are often used in conjunction with conventional medicine to treat minor illnesses. Although not researched, they are also not marketed, and public claims are not made. Occasionally, folklore begins to be marketed aggressively. At that time, clinical trials should be performed to determine if the remedy has therapeutic value.
  • Unproven or untested. These therapies are not based on scientific evidence; therefore, no judgment can be made about their safety or effectiveness. Many accepted therapies could fall into this category as unproven or untested in clinical trials.
  • Investigational or research. Although scientific evidence does not yet exist for these therapies, they are undergoing investigation that uses documented data, accepted research designs for obtaining valid data, peer review of the results and eventual scrutiny by the scientific community. Researchers must meet ethics committees' requirements, and patients must sign an informed consent to participate in these programs.
  • Proven. These therapies have been proven effective by some reasonable degree of scientific evidence. These therapies are currently considered valuable in our present state of knowledge and should become part of conventional care.

With these thoughts in mind, how best should we approach the cardiac patient in our case study? The first step is to begin with care, compassion and understanding. Subsequent steps should include a database search on chelation therapy, an extensive discussion regarding coronary artery disease and the data on secondary prevention, a dialogue regarding the patient's understanding of what conventional therapy can and cannot offer, and a discussion about the patient's expectations regarding chelation therapy. This case is easier than some because readily available data shows that chelation is, at worst, nephrotoxic and, at best, has no proven efficacy.

The patient's desire to pursue this treatment was based mainly on an aversion to conventional therapy. He feared coronary artery bypass surgery and was only willing to accept a stent once he saw the angiogram and realized the immediacy of his needs. After the interventional procedure was completed, despite the evidence supporting reductase inhibitors in secondary prevention, he opted for chelation therapy because he lacked data on its effectiveness and explanations regarding its potential harm. The chelation practitioner had provided him with testimonials from many patients who said they had benefited from the treatment, but when asked to back up these claims with scientific data, the practitioner gave the patient literature that focused mostly on the negative consequences of conventional therapy. Such information clearly exploited the patient's fear of the risks of such therapy. Interestingly, the patient initially refused reductase inhibitor therapy because he did not want to "take a foreign substance into his body" and actually believed chelation with EDTA was a more natural approach. The patient also discounted sound scientific data supporting conventional treatment as nothing more than "what the medical and pharmaceutical industries want you to believe."

After several months of chelation therapy produced no change in his cholesterol, the patient agreed to try reductase therapy as long as he could continue chelation therapy. While trying to respect his autonomy and avoid abandoning him, the physician continued to follow the patient, and a compromise was reached to monitor possible serious side effects of the chelation therapy. Fortunately, the patient developed no obvious problems and once reductase therapy was initiated, he achieved a desirable cholesterol level.

Medicine is a process in evolution. The science of today may be the disaster of tomorrow—remember thalidomide?—and therapies which practitioners are skeptical of may eventually prove to be useful. But the medical community must seek to establish outcome-based standards for all treatments.

Labeling something as alternative does not mean it does not have to stand up to scientific scrutiny. However, if efficacy is demonstrated, the conventional medical community should be willing to accept such therapies and make them available to their patients.

An attitude that only one or the other approach is correct is destructive. We must remember that the patient's best interest is most important. With that in mind, all approaches must include a willingness to undergo scientific review on the basis of valid outcomes-based data. Alternative therapies may have profound negative long-term consequences or exciting positive results. In both circumstances, only a systematic scientific review will bring those results to light.

Acknowledgment: The Ethics and Human Rights Committee would like to thank Richard J. Carroll, ACP-ASIM Member, author of this case history and commentary.

References
1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328:246-52.
2. Defining and Describing Complementary and Alternative Medicine. Panel on Definition and Description, CAM Research Methodology Conference, April 1995. Alternative Therapies. March 1997. Vol. 3 No.2;49-57.
3. Eisenberg DM. Advising patients who seek alternative medical therapies. Annals of Internal Medicine. July 1997; Vol. 127 No. 1;61-69.
4. John Renner, MD, National Council Against Health Fraud, personal communication.


On the Web

Several Web sites provide information on complementary and alternative medicine. Two excellent starting points are http://nccam.nih.gov/and www.quachwatch.com.

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